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nonconforming materials report

Three Key Statements for Investigations

Key statements are those statements that impact more investigation phases than just the one in which they are created. They are vital to a successful investigation. They provide a structure upon which our data hangs and by which we reach conclusions and make decisions. Getting them right does not guarantee a successful CAPA project, nor does getting them wrong guarantee failure.  However if they are not right, your likelihood of success probably depends more upon your luck than your skills. It’s important to recognize the value of writing key statements accurately and constructing them well.

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